FDA Product Code PKC: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
FDA product code PKC covers uncemented metal total anatomic shoulder prostheses cleared for shoulder arthroplasty.
These implants achieve fixation through biological ingrowth or ongrowth into porous-coated surfaces rather than bone cement. Uncemented fixation is preferred in younger, more active patients where long-term biological fixation may outperform cemented alternatives.
PKC devices are Class II medical devices, regulated under 21 CFR 888.3660 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc., Tornier, Inc. and Exactech, Inc..
19
Total
19
Cleared
165d
Avg days
2015
Since
Growing category -
5 submissions in the last 2 years
vs 2 in the prior period
Review times improving: avg
142d
recently vs 173d historically
FDA 510(k) Cleared Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained Devices (Product Code PKC)
19 devices
Cleared
May 01, 2026
FX V135 EASYTECH® Shoulder System
FX Shoulder Solutions, Inc.
Orthopedic
130d
Cleared
Oct 03, 2025
AETOS Shoulder System Stemless Humeral Prosthesis
Smith & Nephew, Inc.
Orthopedic
88d
Cleared
Dec 23, 2024
INHANCE INTACT™
Depuy Ireland UC
Orthopedic
73d
Cleared
Dec 11, 2024
OsseoFit Stemless Shoulder System
Zimmer, Inc.
Orthopedic
167d
Cleared
Nov 20, 2024
AETOS Shoulder System Stemless Humeral Prosthesis
Smith & Nephew, Inc.
Orthopedic
250d
Cleared
Mar 17, 2023
SMR Stemless Anatomic
Lima Corporate S.P.A.
Orthopedic
274d
Cleared
Sep 14, 2022
Tornier Perform Humeral System – Stemless
Tornier, Inc.
Orthopedic
212d
Cleared
Mar 11, 2022
Shoulder Innovations Total Shoulder System
Shoulder Innovations, Inc.
Orthopedic
116d
Cleared
Jan 19, 2022
GLOBAL ICON Stemless Shoulder System
Depuy(Ireland)
Orthopedic
148d
Cleared
Jul 16, 2021
Ignite Stemless Anatomic Shoulder System
Ignite Orthopedics, LLC
Orthopedic
274d
Cleared
Feb 16, 2021
Easytech® Anatomical Shoulder System
Fx Shoulder USA, Inc.
Orthopedic
265d
Cleared
Nov 20, 2020
Arthrex Eclipse Titanium Humeral Head
Arthrex, Inc.
Orthopedic
37d
Cleared
Jul 08, 2020
Arthrex Eclipse Shoulder Prosthesis System
Arthrex, Inc.
Orthopedic
29d
Cleared
Jun 03, 2020
AltiVate Anatomic Canal-Sparing (CS) Shoulder
Encore Medical, L.P.
Orthopedic
194d
Cleared
Apr 29, 2020
Exactech® Equinoxe® Stemless Humeral Components
Exactech, Inc.
Orthopedic
268d
Cleared
Apr 22, 2019
Comprehensive Nano Stemless Shoulder
Biomet Manufacturing Corp
Orthopedic
221d
Cleared
Mar 09, 2018
Exactech Equinoxe Stemless Shoulder
Exactech, Inc.
Orthopedic
130d
Cleared
Dec 18, 2017
Sidus Stem-Free Shoulder
Zimmer GmbH
Orthopedic
180d
Cleared
Mar 04, 2015
Simpliciti Shoulder System
Tornier, Inc.
Orthopedic
79d
About Product Code PKC - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code PKC since 2015, with 19 receiving FDA clearance (average review time: 165 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PKC Product Code
Recent submissions under PKC have taken an average of 142 days to reach a decision - down from 173 days historically, suggesting improved FDA processing for this classification.
PKC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →